Bringing a medical device to market comes with a heavy load of documentation, including the summary of safety and clinical performance (SSCP). If you’re a regulatory affairs manager or medical writer, a summary of safety and clinical performance template helps you standardize your reports and speed up the process across your team. This template gives you a systematic framework for collecting and presenting data in line with regulatory expectations.
When to use the summary of safety and clinical performance template
A summary of safety and clinical performance is a regulatory must-have, especially under EU MDR. If you’re preparing documentation for Class IIa, IIb, or III devices, using a template gives ypu a faster way to stay organized and consistent across submissions.
Use this template to clearly communicate clinical benefits and known risks to notified bodies or end users. It’s especially helpful during conformity assessments, updates for legacy devices, or when launching new models under the same family.
You can also use it to align internal teams, such as regulatory, clinical, and QA, by giving everyone the same format to work with. This approach saves you time and prevents compliance errors while supporting faster approvals down the line.
Key elements of the summary of safety and clinical performance template
This template gives you a roadmap to structure complex data in a way that’s compliant and easy to follow. Here are its core elements:
- Device overview – Start with the essentials: the device name, model number, manufacturer, and its intended use. This section provides quick context to readers unfamiliar with your product.
- Safety information – Highlight known risks, contraindications, and precautions. This part helps users and reviewers quickly assess the risk profile of your device and how those risks are being managed.
- Clinical performance data – Summarize how well your device performs based on real clinical data. Include outcomes, target populations, and supported indications to show both effectiveness and relevance.
- Labelling and usage instructions – Outline the instructions for use, any symbols used, and the validated shelf life. Clear labeling supports safe operation and regulatory approval.
Streamline your reporting process now
Download this template to create reports with more clarity and confidence. It gives you a solid foundation to present your data precisely, from risk summaries to clinical outcomes, so you can focus on quality. With customizable fields, intuitive layout, and clear prompts, you’ll work faster and avoid missing critical details. It’s built to support your team’s workflow, whether you’re handling one device or twenty.